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Studying Volta tAN System to Reduce Blood Loss During Dialysis AV Graft Placement

This study is looking at whether a device called the Volta tAN System, which uses transcutaneous auricular neurostimulation (tAN), can help reduce blood loss during surgery to place a dialysis AV graft (a special connection made for dialysis). You might be able to join if you are between 18 and 75 years old, speak English, and are having a dialysis port placed using a synthetic graft. The study aims to see if using the Volta tAN System before your procedure can lower the amount of blood you lose. We don't know the current recruitment status for this study.

Study design
This is a randomized, double-blind, sham-controlled study with 40 participants. You would be randomly assigned to receive either the active Volta tAN System or a sham (inactive) version.
What's involved
You would receive 30 minutes of active or sham tAN immediately before your dialysis port placement procedure. Blood loss and blood markers will be measured before and during the procedure.
Compensation
Not stated in the trial record.
Follow-up
Blood loss will be measured throughout the procedure.

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NCT06647017

Delivering Transcutaneous Auricular Neurostimulation to Reduce Blood Loss During Dialysis AV Graft Placement Procedures

Recruiting
NAAges 18–75InterventionalTreatment
University Surgical Vascular
~40 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Volta tAN SystemSHAM Volta tAN System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Total Blood Loss
Measured over Throughout procedure

Conditions

Blood Loss, Surgical

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Where it's being run

1 sites across 1 states
Georgia1

Who to contact

David Sailors, MD
[email protected]
(706) 549-8306
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant is undergoing a dialysis port placement procedure using synthetic graft
Participant is between 18 and 75 years of age
Participant is English proficient
Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion

Participant has a BMI ≥ 40
Participant is currently taking a platelet inhibitor medication
Participant has a history of epileptic seizures
Participant has a history of neurological diseases or traumatic brain injury
Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
Participant has abnormal ear anatomy or ear infection present
Person of childbearing age, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
Person who is pregnant or lactating
Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

What this trial measures

  • Mean Total Blood LossThroughout procedure

    Comparison of mean total quantified blood loss in active tAN versus sham tAN groups.